What is the purpose of informed consent in clinical treatment. How does informed consent protect patient rights. Why is patient comprehension essential in the informed consent process. What are the legal requirements for informed consent in medical procedures. How can healthcare providers improve the quality of informed consent.

The Foundation of Informed Consent in Clinical Treatment

Informed consent is a cornerstone of ethical medical practice, serving as a crucial safeguard for patient autonomy and dignity. It ensures that patients have the right to make informed decisions about their healthcare, based on a clear understanding of the proposed treatment, its potential risks, and alternative options.

The concept of informed consent has its roots in legal precedents and ethical considerations. One of the landmark cases that shaped the modern understanding of informed consent is Schloendorff v. Society of New York Hospital (1914), which established the principle that every human being has the right to determine what shall be done with their own body.

Key Elements of Informed Consent

• Disclosure of relevant information
• Patient comprehension
• Voluntariness of the decision
• Competence of the patient to make the decision

These elements form the foundation of a valid informed consent process, ensuring that patients are empowered to make decisions that align with their values and preferences.

Legal and Ethical Framework of Informed Consent

The legal requirements for informed consent have evolved over time, reflecting changing societal values and medical ethics. The case of Canterbury v. Spence (1972) further refined the concept, establishing the “reasonable patient” standard for disclosure. This standard requires healthcare providers to disclose information that a reasonable patient would consider material to their decision-making process.

Are there specific legal requirements for informed consent? Yes, healthcare providers must adhere to both state and federal regulations governing informed consent. These typically include:

1. Providing a clear explanation of the proposed treatment or procedure
2. Disclosing potential risks and benefits
3. Discussing alternative treatment options
4. Answering patient questions and addressing concerns
5. Obtaining voluntary agreement from the patient or their legal representative

Failure to obtain proper informed consent can lead to legal consequences, including malpractice claims and violations of patient rights.

Patient Comprehension: The Cornerstone of Effective Informed Consent

While disclosure of information is crucial, patient comprehension is equally important in the informed consent process. Studies have shown that patients often have difficulty understanding and retaining information provided during the consent process, which can compromise the validity of their consent.

A systematic review by Schenker et al. (2011) found that interventions to improve patient comprehension in informed consent can be effective, particularly those that use multimedia, enhanced consent forms, and extended discussions.

Factors Affecting Patient Comprehension

• Health literacy levels
• Emotional state and anxiety
• Complexity of medical information
• Time constraints during the consent process
• Language barriers

Healthcare providers must be aware of these factors and tailor their approach to ensure that patients truly understand the information presented to them.

Assessing Competence in the Informed Consent Process

Competence to provide informed consent is a critical aspect of the process. Grisso and Appelbaum (1998) outline several abilities related to competence in medical decision-making:

• Ability to communicate a choice
• Understanding of relevant information
• Appreciation of the situation and its consequences
• Ability to reason about treatment options

How do healthcare providers assess a patient’s competence to provide informed consent? They typically evaluate the patient’s ability to understand and process information, weigh the risks and benefits, and communicate a clear decision. In cases where competence is questionable, such as with minors or individuals with cognitive impairments, healthcare providers may need to involve surrogate decision-makers or seek legal guidance.

Challenges in Obtaining Informed Consent

Despite its importance, obtaining truly informed consent presents several challenges in clinical practice. Studies have consistently shown that patients often have poor recall of information provided during the consent process.

For example, Lavelle-Jones et al. (1993) found that only 55% of patients could recall major complications of their surgery, and this recall decreased over time. Similarly, Hutson and Blaha (1991) reported that patients remembered less than half of the preoperative instructions given for informed consent.

Common Challenges in the Informed Consent Process

• Time constraints in busy clinical settings
• Complex medical terminology and concepts
• Patient anxiety and emotional distress
• Cultural and language barriers
• Varying patient preferences for information

Addressing these challenges requires a multifaceted approach, including improved communication strategies, use of decision aids, and tailoring information to individual patient needs.

Improving the Quality of Informed Consent

Given the challenges in obtaining informed consent, there is a growing body of research focused on improving the quality and effectiveness of the consent process. Several strategies have shown promise in enhancing patient comprehension and satisfaction:

1. Use of multimedia presentations and interactive tools
2. Simplified and structured consent forms
3. Teach-back methods to confirm understanding
4. Extended discussions over multiple sessions
5. Involvement of patient advocates or educators

How can healthcare providers assess the effectiveness of their informed consent process? They can use methods such as patient surveys, comprehension tests, and follow-up interviews to evaluate patient understanding and satisfaction with the consent process.

Patient Preferences in Informed Consent

Understanding what information patients actually want to know is crucial for effective informed consent. Several studies have explored patient preferences regarding the content and delivery of information during the consent process.

Newton-Howes et al. (1998) and Dawes and Davison (1994) found that patients generally want to know about the nature of their condition, treatment options, and potential complications. However, the level of detail desired can vary significantly among individuals.

Key Information Patients Typically Want to Know

• Diagnosis and prognosis
• Nature of the proposed treatment or procedure
• Expected benefits and likelihood of success
• Potential risks and complications
• Alternative treatment options
• Recovery process and impact on daily life

It’s important to note that patient preferences may change over time or in different contexts. Healthcare providers should be flexible and responsive to individual patient needs and preferences in the informed consent process.

The Future of Informed Consent in Clinical Treatment

As healthcare continues to evolve, so too will the practice of informed consent. Emerging technologies and changing patient expectations are likely to shape the future of this critical process.

Potential Developments in Informed Consent

• Integration of artificial intelligence to tailor information delivery
• Virtual reality simulations to enhance understanding of procedures
• Blockchain technology for secure and verifiable consent records
• Personalized risk assessment tools
• Continuous consent processes for ongoing treatments

These innovations have the potential to address many of the current challenges in obtaining informed consent, leading to more empowered patients and improved decision-making in clinical treatment.

As we look to the future, it’s clear that informed consent will remain a cornerstone of ethical medical practice. By continually refining our approaches and embracing new technologies, we can ensure that patients are truly informed and empowered partners in their healthcare decisions.

Informed consent for clinical treatment

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Informed Consent for Clinical Trials

en español

On this page you will find information on:

• What is Informed Consent

• Before enrolling in a clinical trial, the following information must be given to each potential research subject

• When Appropriate, one or more of the following elements of information must also be provided in the informed consent document

• A potential research subject must have an opportunity to

• Informed consent may not include language that

To many, the term informed consent is mistakenly viewed as the same as getting a research participant’s signature on the consent form. FDA believes that obtaining a research participant’s verbal or written informed consent is only part of the process. Informed consent involves providing a potential participant with: 

• adequate information to allow for an informed decision about participation in the clinical investigation.

• facilitating the potential participant’s understanding of the information.

• an appropriate amount of time to ask questions and to discuss with family and friends the research protocol and whether you should participate.

• obtaining the potential participant’s voluntary agreement to participate.

• continuing to provide information as the clinical investigation progresses or as the subject or situation requires.

To be effective, the process must provide sufficient opportunity for the participant to consider whether to participate. (21 CFR 50.20.) FDA considers this to include allowing sufficient time for participants to consider the information and providing time and opportunity for the participant to ask questions and have those questions answered. The investigator (or other study staff who are conducting the informed consent interview) and the participant should exchange information and discuss the contents of the informed consent document. This process must occur under circumstances that minimize the possibility of coercion or undue influence. (21 CFR 50.20.)

What is Informed Consent? 

As new medical products are being developed, no one knows for sure how well they will work, or what risks they will find.   Clinical trials are used to answer questions such as: 

• Are new medical products safe enough to outweigh the risks related to the underlying condition?,

• How should the product be used? (for example, the best dose, frequency, or any special precautions necessary to avoid problems),

• How effective is the medical product  at relieving symptoms, treating or curing a condition.

The main purpose of clinical trials is to “study” new medical products in people.   It is important for people who are considering participation in a clinical trial to understand their role, as a “subject of research” and not as a patient. 

While research subjects may get personal treatment benefit from participating in a clinical trial, they must understand that they:

• may not benefit from the clinical trial,

• may be exposed to unknown risks,

• are entering into a study that may be very different from the standard medical practices that they currently know 

To make an informed decision about whether to participate or not in a clinical trial, people need to be informed about:

• what will be done to them,

• how the protocol (plan of research) works,

• what risks or discomforts they may experience,

• participation being a voluntary decision on their part.

This information is provided to potential participants through the informed consent process.   Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work. 

A central part of the informed consent process is the informed consent document. The Food and Drug Administration (FDA) does not dictate the specific language required for the informed consent document,  but does require certain basic elements of consent be included.

Before enrolling in a clinical trial, the following information must be given to each potential research subject:

• A statement explaining that the study involves research.

• An explanation of the purposes of the research.

• The expected length of time for participation.

• A description of all the procedures that will be completed during enrollment on the clinical trial.

• Information about all experimental procedures the will be completed during the clinical trial.

• A description of any predictable risks.

• Any possible discomforts (e.g., injections, frequency of blood test etc.) that could occur as a result of the research.

• Any possible benefits that may be expected from the research.

• Information about any alternative procedures or treatment (if any) that might benefit the research subject.

• A statement describing:

  • the confidentiality of information collected during the clinical trial,

  • how records that identify the subject will be kept

  • the possibility that the FDA may inspect the records.

• For research involving more than minimal risk information including

• an explanation as to whether any compensation or medical treatments are available if injury occurs,

• what they consist of, or

• where more information may be found.

• questions about the research,

• research subjects’ rights,

• injury related to the clinical trial.

• Research subject participation is voluntary,

• Research subjects have the right to refuse treatment and will not losing any benefits for which they are entitled,

• Research subjects may choose to stop participation in the clinical trial at any time without  losing benefits for which they are entitled.

• Contact information will be provided for answers to :

• A statement that:

When Appropriate, one or more of the following elements of information must also be provided in the informed consent document:

• A statement that the research treatment or procedure may involve unexpected risks (to the subject, unborn baby, if the subject is or may become pregnant).

• Any reasons why the research subject participation may be ended by the clinical trial investigator (e.g., failing to follow the requirements of the trial or changes in lab values that fall outside of the clinical trial limits).

• Added costs to the research subject that may result from participating in the trial.

• The consequence of leaving a trial before it is completed (e.g. if the research and procedures  require a slow and organized end of participation).

• A statement that important findings discovered during the clinical trial will be provided to the research subject.

• The approximate number of research subjects that will be enrolled in the study.

A potential research subject must have an opportunity to:

Usually, if one is considering participating in a clinical trial, he or she may take the consent document home to discuss with family, friend or advocate.

An investigator should only get consent from a potential research subject if:

The information must be in language that is understandable to the research subject.

Informed consent may not include language that:

• the research subject is made to ignore or appear to ignore any of the research subject’s legal rights,

• releases or appears to release the investigator, the sponsor, the institution, or its agents from their liability for negligence.

Participating in clinical trials is voluntary.  You have the right not to participate, or to end your participation in the clinical trial at any time. Read the informed consent document carefully.  Ask questions about any information you don’t understand or find confusing.

Draft Guidance: Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors

3. Informed consent rule

rule
informed consent
ensure respect for
patients or subjects in biomedical
experiments as individuals {cf. For
comparison ch. II on the principle of respect
autonomy), as well as, of course,
minimize the threat to their health,
socio-psychological well-being
and moral values ​​due to
dishonest or irresponsible
actions of specialists (see the same chapter
on the principle of “do no harm”). What already
noted (Chapter V) in the analysis of models
relationships between doctors and patients
surgery, chemotherapy,
prolonged hospitalization and many
other types of medical intervention
can have a significant impact on
opportunities to implement life plans
person. Application of the rule
informed consent provides
active participation of the patient in the choice
methods of treatment, optimal not only
from a medical point of view, according to and from the point of view
view of life values
person.

According to
this rule, any
medical intervention (in
including attracting people to
as a test subject in biomedical
study) must
as a prerequisite to include
special procedure for obtaining
voluntary consent of the patient or
subject on the basis of adequate
information about the objectives of the proposed
intervention, its duration,
expected positive effects
for the patient or subject, possible
discomfort (nausea, vomiting,
pain, itching, etc.), risk to life,
physical and/or sociopsychological
well-being. Necessary
also inform the patient about
availability of alternative treatments
and their comparative effectiveness.
Essential
information element should be
information about the rights of patients and subjects
in this treatment-and-prophylactic or
research institution
and how to protect them when
they are hurt in one way or another.

Historically
informed consent rule
arose in connection with the investigation
“scientific” activities of the Nazi
Medicon in concentration camps during the Second
World War (see Ch. XIV). ”After
the Nuremberg Trials, which
demonstrated evidence of
monstrous medical experiments
in concentration camps, the question of consent became
one of the main for biomedical
ethics. The term “informed
consent” (m! ogtes1 sopkep!) appeared
not earlier than ten years after
process, and it was studied in detail
somewhere in the year 1972″ (21). Indeed,
and the Nuremberg Code was formulated
norm voluntary
consent; informed
the same agreement, as we will see a little later,
is more stringent.

Should
also note that both in the world and in
domestic practice and earlier
there was a tradition of obtaining consent
patient for surgical
treatment methods.

However
broader informed consent rule
simply obtaining consent before
just by aiming at
ensuring voluntariness and freedom
selection of patients and subjects by their
adequate information.

IN
present receiving rule
informed consent of patients
and those
who is involved in clinical
tests or biomedical
research, became
generally accepted norm. In the Constitution
Russian Federation in chapter 2, article
21 the following provision is written: “No one
cannot be without voluntary consent
subjected to medical, scientific or
other trials”. In “Fundamentals
legislation of the Russian Federation on health protection
citizens” this provision is specified
in articles 43 and 32. Article 43 reads: “Any
biomedical research involving
person as an object
carried out only after receiving
the written consent of the citizen.
A citizen cannot be forced to
participation in biomedical research.
Upon obtaining consent for a biomedical
study to a citizen should be
provided information about the goals,
methods, side effects, possible
risk, duration and expected
research results. Citizen
has the right to refuse to participate in
research at any stage.”

Article
32 extends the principle of informed
consent for cases medical
intervention: “Required
precondition for medical
intervention is informed
voluntary consent of the citizen.
Consent to medical intervention
minors (under 15) or
incapacitated persons is obtained from their
legal representatives. In emergency
cases where the patient’s condition is not
allows him to express his will, question
medical intervention is decided
either by a panel of experts, or
attending (duty) doctor, followed by
administration notice
medical institution.

What are
purpose of application in medical practice
and biomedical research regulations
informed consent? According to
Beechamp and Childres, three of them:

I.
Ensure respect for
patient or subject in a biomedical
research as an autonomous person,
which is entitled to exercise free
selection and control of all procedures
or actions taken in the process
treatment or scientific research with
his body.

2. Minimize
   possibility of moral or material
   damage that may be caused
   patient due to dishonest
   treatment or experimentation.

Create
conditions conducive to increasing
sense of responsibility of medical
workers and researchers for moral
and physical well-being of patients
and subjects (21).

Should
also note the importance of obtaining
informed consent for
socio-psychological adaptation
to new conditions of life that can
occur as a result of medical
intervention. Discussion with a doctor
treatment options, goals and likely
consequences of a particular treatment
procedure creates a psychological
readiness for necessary adjustments
in lifestyle and, as a result,
contributes to more effective adaptation.

rule
informed consent not only
regulates a certain procedure,
pre-serious medical
intervening or participating in an experiment,
but also aims at the content
interpersonal communication between doctors and patients
or test subjects during the whole process
treatment or research. WITH
methodological point of view is useful
distinguish procedural
and
moral
content rules
informed consent. In procedural
in relation to
in what specific forms
is expressed. These are the questions:
whether information is conveyed orally or
in writing, in how much detail,
should the form of informed
consent to sign other than the attending
doctor and patient as well as a third party in
as a witness, as organizational
the patient is protected or
subject from possible pressure or
manipulation of their choices.

procedural
aspects are regulated by the national
legislation, orders and
instructions of the Ministry of Health, rules
internal routine of treatment and prophylactic
and research organizations.
Existing in the domestic medical
practice and scientific activity tradition
verbal communication has something
advantage,

What
she looks less official, more
confidentially. If we take into account that
a large part of the population is missing
contractual experience, then probably
it is more in line with existing
social skills.

Together
with that, verbal information is practically
eliminates the possibility of independent
control over what is actually reported
patient or subject, reduces
responsibility of physicians and researchers
for the quality of information and thus
creates conditions for violation of rights
patients and subjects. It seems that
approach to this issue should be
differentiated. In cases where
medical intervention
or scientific research involves
serious risk to life
or the health of the patient (subject),
the best procedure would be a written
informing form (protocol
informed consent). Today,
when increasingly common in
our country are becoming lawsuits
patients or their representatives
about damage caused by treatment,
this way of informing is essential
enhances legal security and
medical workers. In the same cases
when no serious risk is foreseen,
it is advisable to keep the oral form
conversations.

Procedure
obtaining informed consent
designed to realize the content
moral idea, the core of which
constitutes a patient confession or
subject as a person who
entitled to participate with
healthcare professionals in taking
solutions. In the form of certain ethical
norms content rules informed
consent is expressed in
ethical codes and declarations,
adopted by international and national
medical associations and associations.

IN
In this regard, it is of particular importance
such a document as adopted in 1996.
Council of Europe “Convention for the Protection
human rights and dignity in relation to
using the achievements of biology and
Medicine: Convention on Human Rights
and biomedicine”. With accession to
Russia, this Convention acquires in
our country the force of law; while in
cases where the norms of the Convention come
contrary to the norms of the Russian
legislation, priority is given
the rules of the Convention. According to Art. 5 Convention,
any
medical
intervention can be
only after the person subjected to
such interference, will give him
voluntary informed consent,
Further in Art. 6, 7, 8 and 9 of the Convention are formulated
conditions for medical
intervention in cases where
the patient’s consent to certain
reasons is impossible. For
detailed discussion of the rule
informed consent is convenient
use Beechamp’s suggestion and
Childres theoretical decomposition
this principle into components
elements. From this point of view, the structure
rules has the following form:

1. “Threshold”
   elements (preconditions):

A)
patient competence (in the sense
understanding and decision making), b)
voluntary decision making.

2. Informational
   elements: a) transfer procedure
   essential information, b) offer
   recommendations (action plans), c) act
   understanding.

3. Elements
   consent: a) making a decision (in favor of
   some plan), b) authorization
   (certain plan) (21).

Competence
patient or subject is
necessary
prerequisite participation
in the process of obtaining informed
consent. The law provides enough
a simple rule for two
states: the patient’s competence or
subject or incompetence.
Persons younger than
15 years old, as well as citizens recognized and
incompetent in the prescribed manner.
Right to give informed consent
transmitted from an incapacitated patient
his legal representatives. Law in
in this sense expresses only some
generally accepted minimum moral
normalization, leaving aside the whole
a number of controversial and ambiguous with ethical
situations point of view.

IN
in particular, insufficiently taken into account
the child’s right to information
about your physical and mental
condition and control over
committed to his body in the process
healing. Certainly not a teenager
over 15 years of age, not mature enough to
in order to take without the help of adults
responsible decisions regarding
methods of its treatment. But it does not mean,
that an adult can always fully
replace in the decision-making process,
Is it possible
so
categorically ignore personality
minor patient? Probably,
should be more justified
a differentiated approach that
depending on the level of individual
development provided the child with more
or less rights to participate in making
decisions about your treatment.

Such
norms are contained, in particular, in
the aforementioned Convention of the Council of Europe,
in Art. 6 which says: “Opinion
the minor himself should
consider as a factor
which increases with age and
degree of its maturity”. It should be noted that
that in the “Civil Code of the Russian
Federation” legal capacity
juvenile increases as
maturity of the citizen. Already
six-year-old citizens get the right
do minor household chores
transactions, dispose of certain
within the funds provided
their parents, etc. From the age of fourteen
the scope of these rights is greatly increased.
Probably a similar approach should be
apply to capacity
minors as far as
their participation in making decisions about methods
their treatment.

WITH
moral point of view seems
flawed common practice,
in which adolescents are violent or
deceitfully coerced into operational
intervention. Difficulty getting them
agreement, which is indeed the case
in some cases, only indicates
urgent need
clinical and psychological education
doctors and active connection
professional psychologists for approval
communication problems between minors
patients and physicians. It should also
take into account the possibility that
the patient’s representative may
decision that is at odds with the interests
the patient himself. In the latter case
it is the duty of physicians to advocate for the interests
child and take legal steps,
which would restrict the rights of legal
representatives in this matter.
For example, there have been cases where
parents out of ignorance or under the influence
prejudice refused transfusions
blood or a life-saving
child operation. In situations like this
interests of disabled patients
must outweigh the rights of their legitimate
representatives.

Solution
patient is considered voluntary,
if
when it was taken, the patient did not have
coercive influence from outside. Beechamp and
Childres distinguish various forms of such
influences that could significantly
violate voluntariness (21). This –
direct coercion to
certain decision by threat,
authoritarian decision-making and
manipulation of information that, outwardly
being objective, is selected in such a way
in such a way that the patient or subject
takes advantage of the physician or
researcher’s decision.

The most
common threat, which is often
affects patients, – probability
refusal of physicians from treatment or refusal
(restriction) in free rendering
help. At the same time, it is not necessary
that the doctor or researcher really
threatened the patient in this way.
The patient may fear that with him
will do so if it is not
agree to participate in the study
or on the method suggested by the doctor
diagnosis or treatment. Therefore, when
obtaining informed consent
special attention needs to be paid
patient to the fact that his refusal is not at all
does not diminish his rights or accessibility
alternative medical methods
intervention.

Any
disease, but especially severe,
serious impact on the patient’s psyche,
in many cases limiting it
ability to take
solution. Helpless state makes
its especially prone to direct
authoritarian dictate, In such a situation,
even if there is no reason to doubt
patient competence,
give him an opportunity to discuss
their position with loved ones. Necessary
also remember the patient’s right to
advice from independent experts,
which is provided to him by the existing
legislation and inform him of
this right.

How
already noted, the oral form of transmission
information to the patient or subject
makes it possible to manipulate
decision. Silence, misinformation
on the comparative risk of alternative
treatments, hiding information
about negative previous experiences
application of this medical
interference, exaggeration of chances
on the success of the proposed study
or medical intervention – all
this may violate the principle of voluntariness.
It should also be borne in mind that such
violation can be
doctors unknowingly. Passionate

botkoy
new natural scientist treatment method
tends to exaggerate
advantages of its innovation in comparison
with existing practices. In this sense
written completion of a special form
informed consent creates
more control over
objectivity of the transmitted information.
Serious guarantees in this respect
can be obtained if
all applications for testing and
research will be mandatory
undergo an independent review
ethical committee.

Discussing
problems of ensuring voluntariness
with the consent of the patient or
subject, we have already paid attention
on the extreme importance of certain procedural
information transfer issues. Consider
more question about content
information provided to the patient. how much,
how and what to tell the patient? General scheme
what needs to be communicated to the patient
defined by law, which
cited above. But the question remains –
how much information should be given
patient?

At
determining the scope and content
reported information can
follow special rules
called in bioethics
“standards
information. ” Proposed
several such standards, among
which are of greatest practical interest
represent the “medical professional
standard”, “rational standard
personality” and “subjective standard”.

According to
first – professional
standard, – volume
and the content of the information is determined
the practice traditionally
this medical community. In progress
learning future doctor takes over from
teachers not only methods of healing,
but also basic communication skills
patients. This is a spontaneously folding
standard in medical practice that
usually unconsciously assimilated by physicians.
In a stable society with an established
health system and established
publicly accepted moral
standards of medicine this standard
effective enough.

However
in today’s Russian society,
in the process of socio-political
transformations, during which changes
its structure and healthcare, and
many moral standards
stack up, an appeal to traditional
norms can only matter before
variable
knowledge. Conditions have changed significantly
medicine, so you need to earn
new traditions and new moral
standards corresponding to modern
conditions.

I think
under these conditions more suitable standard
rational personality, which
as if to imagine
“average citizen” and answer
to the question: what information and in what
volume he may need in order to
to make an informed decision,
regarding consent or disagreement to
medical intervention either
on
participation in biomedical research?
The physician or scientist must be able to model
to the imagination of rational behavior
your patient or examinee and
build awareness tactics
according to the result of such
thought experiment.

Subjective
standard offers
besides what might be useful
know the “average patient” at
rational decision making, take into account
Yeshe and the specifics of the interests of this
specific individual. If, for example,
This patient has a history of
information about their previous
kidney disease, then when informing
about the risk of complications
particular attention to the possibility of renal
violations, although for the “average
patient” they are not typical.
“Subjective standard” outlines
tactics of individualization of transmitted
information.

Because the
the educational level of the patient,
particularly in the field of medicine,
be low, then there are serious
doubts that, in principle, in a number of
cases possible effective
understanding im
reported
information. B-champ
and Childres suggest the next exit
from the position: “Successful informing
medically ignorant patients about new
and quite special items
can be achieved using
to clarify the analogy from ¹
their daily life. Eg,
a professional to explain the risk,
expressed in numerical form,
apply comparisons with probability
known to the patient from the previous
experience of the risk of any action – risk
driving a car or working with
electrical appliances” (21). With
practical point of view is better not
use a lot of technical terms,
which may or may not be understood at all,
or misunderstood.

Important
also take into account the psychological impact
words used. Information about
that the probability of survival is 50%,
sounds more reassuring than the message
that the likelihood of death
outcome is 50%, although with a mathematical
point of view they are, of course, equivalent.
Information provided to patients
even a low risk of death
during any medical
interventions tend to drastically reduce
its preference, although distant
the consequences could be much more
favorable. Understand the information
always means to accept it. Sick
cancer patient, even knowing exactly verbally
form your diagnosis, it may be
sure that he is actually healthy
or the disease is benign
character. Therefore, based on false
confidence, he can refuse
chemotherapy offered to him or
surgical treatment.

How
show sociological research,
not all patients are concerned
desire to know more about
upcoming treatments and related
risk with them, trusting your choice
treating doctor. According to some reports,
number of uninterested in receiving
information on these topics can reach
60%. The patient’s opinion should be respected and
not to impose on him the information that
he doesn’t want to know. So, in Art. 31 “Osnovy
legislation of the Russian Federation
on the protection of the health of citizens,
that “health information
cannot be granted to a citizen
against his will.” At the same time, participation
people
in
clinical trial or biomedical
experiment is unacceptable without it
informing and awareness im
research content and related
risk with him.

However
whether the patient’s unwillingness to receive
medical information about
forthcoming intervention frees
doctor from a moral obligation,
prescribed by the rule of informed
consent? If under medical information
understand only what is relevant
to the biological level of the disease,
then you can refrain. The patient may
really not interested in data
about the dynamics of enzymes or amino acids
in your blood, anatomical details
advancing a probe or catheter, etc.

hardly
whether, however, there is a patient, not
interested in
obtaining information about possible
consequences of diseases
ia
biographical level. For example, about
change in appearance
stripes, appearance on the face of disfiguring
spots or scars, etc.), limitation
ability to work, the risk of significant
financial costs, reduction or
cessation of normal sexual activity
or any other violation of habitual
lifestyle. This aspect of medical
information is easily understood by people with
any education. Therefore, the rejection
obtaining information, most likely
based on the wrong assumption about
that we are talking about biological
data, not biographical consequences
(see ch. V),

Doctor
can hope he’s better than
patient knows what is good for
the latter, and what is bad in terms of
restoration of impaired health.
But speaking of preferences
or undesirability of certain
consequences of treatment on biographical
level, then this is the area of ​​competence
only the patient himself, and the doctor
entitled to rely on no more than
the role of an authoritative adviser. –

Having received
objective information about medical
intervention or scientific research,
the patient or subject must take
decision – give your consent or refuse
in him. Acceptance
solutions – it
independent process, which
prepared by an objective
informing. It takes time.
Therefore, the patient should not be forced or
examinee to sign the form
consent immediately upon receipt
information. You need to give time to
reflection, advice to relatives or
consultation with experts. Necessary
also note that the consent given
subject or patient, subsequently
may be revised or withdrawn.
Domestic legislation
provides for the right of the test subject to
termination of participation in the study
at any stage, as well as the right of the patient
to refuse treatment.

What
concerns authorization,
then
like informing, it can
carried out both orally and in writing
form. Essentially, it means
patient’s willingness to enter
certain types of contracts
who will connect him with doctors,
helping him. These relationships
define mutual legal and moral
obligations of the parties
forms and degree of responsibility.

Some
remarks regarding the linkage of the rule
informed consent and issues
trust in doctor relationships
– patient”. Historically,
so that the rule of the informed
consent was initially received by the most
detailed conceptual design
in the USA, so its coverage is here
focused mainly on American
sources. It also has its own historical
grounds and the fact that this rule
discussed mainly in connection with
detected cases of serious
violations of rights and interests by doctors
patients in scientific or commercial
purposes. Moreover, in practice
American and Western European
health care procedures
informed consent were introduced
mainly to minimize
the risk of these disorders.

No
no reason to assume that
risk for Russian healthcare
use of patients by dishonest
experimenters as “guinea pigs”
rabbits” or the risk of manipulating them
rights and economic interests
less than in the West. Therefore, we are convinced
that the informed consent rule
extremely important for normal
development of modern moral and
legal standards of medicine in our
country.

However,
like any medical intervention,
practical transformation and improvement
doctor-patient relationship based on the new
moral standard may have its own
negative consequences, their unfavorable
side effects.

If
informed consent principle
understood solely as a measure
against the threat of harm to patients
and subjects from doctors, then when
its transformation into is necessary
precondition for any
medical intervention he
may be a significant factor
disrupting confidence in healthcare
professions. The patient is told, “You
should control the actions of doctors,
otherwise you (your health and your
interests) is in danger.”
suspicion and feelings of danger,
can certainly play a negative role
role. It is more reasonable to assume that
prevention of noted dangers
is important, but not the main
task. Moreover, achieving this
(defensive) purpose can be
by-product of implementation
more morally benevolent
installation.

Practically
no such diseases or pathological
conditions under which it would apply
one single treatment. Usually
there are several of them, for example, using
various pharmacological preparations,
physician may reasonably believe that
one of the medicines would be better for
cupping unfavorable
symptoms.
But he must decide together.
with a patient who knows better than a doctor
about their financial possibilities, about their
habits, daily routine, etc., finally,
about lifestyle in general. This is his personal
knowledge, which is also important for acceptance
optimal decision on the choice of
other method of healing.

That’s why
informed consent rule
can be understood as a norm of dialogic
communication between doctor and patient to
coordination of the optimal both from the position
doctor, and from the standpoint of the patient himself
choice of method of medical intervention.
Such a discussion should include
all the elements of the rule described above
informed consent. If this
requirement is met, then
natural result is reduced
risk of harm to health and
the interests of patients.

Doctor
and the patient becomes the same
equal partners within
social health institute.
The informed consent rule in
these conditions is not an end in itself,
but a means to ensure partnership
stakeholder dialogue.

Informed voluntary consent – a guarantee for all

• health care procedures
• /
• Informed voluntary consent is a guarantee for all

INFOGRAPHICS

The obligation of citizens in the field of health protection and the need to take care of maintaining their health

Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation”

Article 27. Obligations of citizens in the field of health protection

1. Citizens are obliged to take care of their health.

2. Citizens, in the cases provided for by the legislation of the Russian Federation, are obliged to undergo medical examinations, and citizens suffering from diseases that pose a danger to others, in cases provided for by the legislation of the Russian Federation, are obliged to undergo a medical examination and treatment, as well as to engage in the prevention of these diseases.

3. Citizens undergoing treatment are required to comply with the treatment regimen, including those determined for the period of their temporary incapacity for work, and the rules of the patient’s behavior in medical organizations.

Materials of the district professional creative competition for specialists with secondary medical education and higher nursing education “Health. Medicine. Family”, dedicated to the Year of Health of Yugra – 2017 and dedicated to the International Day of the Nurse

Informed voluntary consent is a relatively new phenomenon for us. Previously, doctors often did not see the need to explain to the patient what kind of operation he would have, what were its possible outcomes. Nowadays, no operation or major medical procedure is performed without the permission of the patient. This protects the rights of both parties: both doctors and patients.

Who signs the voluntary informed consent?

Informed voluntary consent (IDS) is an inalienable right of the patient. It consists in the voluntary acceptance by the patient or his legal representative of the medical intervention proposed by the doctor, the type of examination and treatment. To do this, the doctor in an accessible form gives detailed information about the upcoming intervention, possible complications, options for procedures and conditions for their provision. Voluntariness in this case means the absence of coercion in the form of threats, authoritarian imposition of a medical opinion, manipulation of information.

The concept of informed voluntary consent was first legislated in the Russian Federation in 1993. At present, in Russia, informed voluntary consent “is a necessary condition for the provision of medical care” (in accordance with Article 20 of Federal Law No. 323 “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation”, and the procedure for obtaining it is established by Order of the Ministry of Health of the Russian Federation dated 20.12. 2012).

The right to consent is directly related to legal capacity. In accordance with Article 28 of the Civil Code of the Russian Federation, children under 6 years of age are completely incapacitated, and consent for them is given by legal representatives. Minors from 6 to 18 years of age have limited legal capacity (Article 26, 28 of the Civil Code of the Russian Federation), however, from the age of 15, according to the Federal Law “On the Basics of Protecting the Health of Citizens in the Russian Federation”, adolescents have the right to voluntary informed consent to medical intervention. Thus, from 6 to 15 years of age, legal representatives give consent for a minor, from 15 to 18 years of age – minors independently, although they can use the help of parents or legal representatives, nevertheless sign the form on their own.

Adult citizens give voluntary informed consent on their own. Citizens of age who have been declared legally incompetent give informed voluntary consent through guardians.

Without consent

In some cases, voluntary informed consent from the patient is not required.

According to Part 9 of Art. 20 of Law No. 323-FZ, medical intervention without the consent of a citizen, one of the parents or other legal representative is allowed:

1. If medical intervention is necessary for emergency reasons to eliminate the threat to a person’s life and if his condition does not allow him to express his will or there are no legal representatives (in relation to persons specified in Part 2 of Article 20 of Law No. 323-FZ). The urgency of indications for medical intervention is determined by a council of doctors. In the event that it is impossible to convene a consultation – the attending (duty) doctor directly, with such a decision entered into the patient’s medical documentation.

2. In relation to persons suffering from diseases that pose a danger to others. The list of diseases that pose a danger to others was approved by Decree of the Government of the Russian Federation of December 1, 2004 No. 715 (viral fevers, leprosy, malaria, glanders, anthrax, plague, etc.).

3. In relation to persons suffering from severe mental disorders. Features of obtaining consent to medical intervention in relation to persons suffering from severe mental disorders are established by Art. 11 and 29Law of the Russian Federation of July 2, 1992 No. 3185-1 “On psychiatric care and guarantees of the rights of citizens in its provision.”

4. In relation to persons who have committed socially dangerous acts (crimes).

5. When conducting a forensic medical examination and (or) a forensic psychiatric examination. The procedure for making a decision on medical intervention in the above cases is defined in Part 10 of Art. 20 of Law No. 323-FZ.

Right of withdrawal

The patient has the right to completely refuse medical intervention, as well as to demand its termination. He may also refuse a particular medical intervention if there is a choice of various medical manipulation options.